single-use systems and consumables: the perfect match for adc manufacturing · mab adc...

Single-use Systems and Consumables:The Perfect Match for ADC Manufacturing

mAb

ADC (Antibody-drug conjugates) manufacturing and operator safety go hand in hand. Ready-to-use, pre-flushed and fully contained systems for prior- and post-use will make your life easier, giving you greater safety, reliability and flexibility. Single-use equipment eliminates the drawbacks and risks of conventional stainless steel systems that require large amounts of water and agents for intensive cleaning, and involve the risks of cross-contamination and residual cytotoxin even after cleaning. Single-use systems will give you the peace of mind that your ADC manufacturing operations will consistently provide the highest product quality for the benefit of your customers and patients alike.

Ready-to-use Systems for ADC Manufacturing

Single-use Systems and Consumables:The Perfect Match for ADC Manufacturing

mAb

LinkerDrug

High Cost Efficiency – Lower CAPEX

– Shared equipment for multi-product manufacturing

– Less biowaste to handle

Increased Operator and Product Safety– Reduced cleaning

– Compatibility tests

– One film for all

Reduced Time-to-Market – Fast delivery of equipment

– Scalability – from lab scale to commercial manufacturing

Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com

EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen

Phone +49.551.308.0

Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen

Phone +49.5665.407.0

FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex

Phone +33.442.845600

Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex

Phone +33.442.845600

AustriaSartorius Stedim Austria GmbHModecenterstrasse 221030 Vienna

Phone +43.1.7965763.18

BelgiumSartorius Stedim Belgium N.V.Rue Colonel Bourg 1051030 Bruxelles

Phone +32.2.756.06.80

HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi

Phone +36.23.457.227

ItalySartorius Stedim Italy S.r.l.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)

Phone +39.055.63.40.41

NetherlandsSartorius Stedim Netherlands B.V.

Phone +31.30.60.25.080

[email protected]

PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn

Phone +48.61.647.38.40

Russian FederationLLC “Sartorius Stedim RUS”Vasilyevsky Island5th line 70, Lit. A199178 St. Petersburg

Phone +7.812.327.53.27

SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)

Phone +34.913.586.098

SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen

Phone +41.52.354.36.36

U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ

Phone +44.1372.737159

UkraineLLC “Sartorius Stedim RUS”Post Box 440 “B”01001 Kiev, Ukraine

Phone +380.44.411.4918

AmericasUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716

Toll-Free +1.800.368.7178

ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires

Phone +54.11.4721.0505

BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil

Phone +55.11.4362.8900

MexicoSartorius de México, S.A. de C.V.Libramiento Norte de Tepotzotlan s/n,Colonia Barrio Tlacateco,Municipio de Tepotzotlan,Estado de México,C.P. 54605

Phone +52.55.5562.1102

[email protected]

PeruSartorius Peru S.A.C.Avenue Alberto del Campo 411 Floor 12 – The Office15076 – San Isidro, Lima

Phone +51.1.441 0158

Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175

Phone +61.3.8762.1800

ChinaSartorius Stedim (Shanghai) Trading Co., Ltd.3rd Floor, North Wing, Tower 1No. 4560 Jinke RoadZhangjiang Hi-Tech Park Pudong DistrictShanghai 201210, P.R. China

Phone +86.21.6878.2300

Sartorius Stedim (Shanghai) Trading Co., Ltd.Beijing Branch OfficeNo. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300

Phone +86.10.8042.6501

Sartorius Stedim (Shanghai) Trading Co., Ltd. Guangzhou Branch OfficeRoom 1105Xing Guang Ying Jing BuildingNo. 119, Shui Yin Road Yue Xiu District, Guangzhou 510075

Phone +86.20.3836.4193

IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India

Phone +91.80.4350.5250

JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan

Phone +81.3.4331.4300

MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia

Phone +60.3.8996.0622

SingaporeSartorius Stedim Singapore Pte. Ltd.10 Science Park Rd The Alpha #02-13/14Singapore Science Park IISingapore 117684

Phone +65.6872.3966

South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400

Phone +82.31.622.5700

www.sartorius-stedim.com



Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700


Palletank (2,000 L)

After you have thawed mAbs in a controlled process, you need to ensure they are transferred aseptically. Sartorius Stedim Biotech fully contained single-use equipment is designed to help you meet the highest product and operator safety levels for transfer.

A homogeneous solution is essential for reproducible processes. Single-use systems based on levitation mixing technology enable you to conveniently optimize the safety of your ADC products.

Homogenization of Thawed mAbs

Palletank (200 L)

Flexboy® Lab Scale

Clinical Phase

Commercial Manufacturing

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Multifunctional System

Jacketed Palletank (3,000 L)

Whether you need to reduce disulfide bonds or modify lysine residues in your mAbs to prepare them for conjugation, Sartorius Stedim Biotech single-use technologies are the perfect solution. The reason: You can readily use these robust technologies during the different phases ranging from development to commercial manufacturing to increase your operator and product safety right from the start. They can accomplish all these steps.

Get the best of both worlds with Sartorius Stedim Biotech: Conjugate your cytotoxin to your antibody and quench the reaction afterwards. In addition, control your DAR (Drug-to-antibody ratio) by precise dosing of your drug linker solution.

Take advantage of maximum process control by mixing, heating and cooling, sampling and dosing your additions to obtain the perfect ADC.

Modification of mAbs

Conjugation and Quenching

FlexAct® for Conjugation and Quenching

Jacketed Palletank (50 L)

MYCAP™Biostat® B with UniVessel® SU

FlexAct® for Conjugation and Quenching – Dual Mode


1 LevMixer® is a trademark of Pall Corporation and this product uses Pall patented LevMixer® technology. All information on patents can be found at Pall.com/patents.

1 LevMixer® is a trademark of Pall Corporation and this product uses Pall patented LevMixer® technology. All information on patents can be found at Pall.com/patents.


Palletank for LevMixer®1 (1,000 L)

Reduce volumes and increase concentra-tions, while minimizing your contamination risk and operational costs with one-bag operation – no product transfer between conjugation and concentration. Our perfor-mance: Sartocon Ultrafilter ensure the removal of toxic components and solvents at low flux and short process time, avoiding aggregation and product loss.

Safety comes first: Protect your product and operator by using self-contained, preflushed and presterilized Sartocon Self Contained Unit (SCU) ultrafilters for prior- and post-use process integrity.

Bring your ADC in shape:Adjust the conductivity and pH, and add excipients with the highest accuracy.

Control your process parameters continuously and store your intermediate product under carefully controlled conditions, while reducing your manufac-turing footprint with shared Sartorius Stedim Biotech equipment ready to move when you are.

Concentration and Diafiltration Formulation

Palletank for LevMixer®1 (50 L)

FlexAct® for Ultra-| Diafiltration

SARTOFLOW® Alpha plus SU UniVessel® SU

FlexAct® for Ultra-| Diafiltration – Dual Mode


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Sartopore® Platinum T-Style MaxiCaps®

Celsius® FT100

Ensure product safety by using sterile connectors and contained technologies to reduce contamination risks right from the beginning. On top of these Sartorius Stedim Biotech products, benefit from our proven solutions for bioburden reduction. So that your ADCs will successfully meet all current safety standards.

Intermediate or long-term storage? It’s your choice! Freeze your ADCs in a fully controlled process to ensure conservation of all their properties. Prepare them for shipment to one of your Fill and Finsih sites or partners worldwide and ship these products around the globe in a safe and fast way by using our Freeze and Thaw technologies.

Sterile Filtration Freezing

Sartopore® Platinum MidiCaps®

Celsius® Pak (16.6 L)

Celsius® FFT (4 L)

Sartopore Platinum®

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Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700




Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700




Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700




Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700




Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700




Phone +49.551.308.0


Phone +49.5665.407.0


Phone +33.442.845600


Phone +33.442.845600


Phone +43.1.7965763.18


Phone +32.2.756.06.80


Phone +36.23.457.227


Phone +39.055.63.40.41


Phone +31.30.60.25.080

[email protected]


Phone +48.61.647.38.40


Phone +7.812.327.53.27


Phone +34.913.586.098


Phone +41.52.354.36.36


Phone +44.1372.737159


Phone +380.44.411.4918


Toll-Free +1.800.368.7178


Phone +54.11.4721.0505


Phone +55.11.4362.8900


Phone +52.55.5562.1102

[email protected]


Phone +51.1.441 0158


Phone +61.3.8762.1800


Phone +86.21.6878.2300


Phone +86.10.8042.6501


Phone +86.20.3836.4193


Phone +91.80.4350.5250


Phone +81.3.4331.4300


Phone +60.3.8996.0622


Phone +65.6872.3966


Phone +82.31.622.5700


single-use systems and consumables: the perfect match for adc manufacturing · mab adc...

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